What are your main responsabilities?
Manage team of 7 people located in the US and in France.
Define, develop and implement regulatory strategies and policies for the successful and fast registration of IVDs worldwide belonging to the Immuno Assay franchise, and in charge of regulatory approvals for Europe (CE Marking), the US (FDA) and China (NMPA).
Ensure that relevant Corporate regulatory processes are established, continuously improved and followed.
- Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team, supported by an efficient regulatory watch. Oversee and ensure compliance with regulatory procedures and work practices Review, analyze and report on the effectiveness of the regulatory processes (definition of KPIs)
- Provide expertise in translating regulatory requirements into practical, workable plans
- Ensure timely execution of regulatory submissions in line with company strategies
- Establish registration plans and review periodically with relevant contacts to ensure that resources are efficiently deployed
- Assist in drafting and validating answers to questions from regulatory authorities; monitor progress and escalate delays, problems as necessary
- Attract and develop the relevant profiles and competencies for an efficient RA organization and ensure human capital planning
- Maintain a positive team spirit and lead by ethical principles
- Establish, consolidate and monitor department budget.
What is your profile?
- Excellent knowledge and understanding of regulatory submissions with Health Authorities with more than 6 years of practice in the field of IVD’s/MDs in an international environment
- Strong scientific background (Master Degree, PhD…)
- Strong leadership
- Experience managing and coaching staff (also remotely), at ease in an international environment
- Capacity to influence, challenge and negotiate
- Clear communication to internal/external stakeholders
- Strategic and analytical thinker and problem-solver, planner with excellent organizational skills
- Participation to local and/or international trade, associations
- Good understanding of QMS requirements (design and change control processes), as well as of audits/inspections.
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.